BRONCOCHEM

Manufacturer
LABORATORIO MAGNACHEM INTERNATIONAL SRL
Effective date
2025-03-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:24

Label at a glance#

ProductBRONCOCHEM MAXIMUM COUGH NIGHT
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PYRILAMINE MALEATE
Label structure12 sections

Indications and uses

Temporarily relieves these symptoms in all formsof acute, subacute, and cronical cough of any origin, it is very effective in colds, rhinitis, pharyngitis, laryngitis, dry cough, smokers cough, ashma, nervous cough.

Dosage and administration

Do not exceed 4 doses in a 24 hour period. Adult and children 12 years and older: 10 mL 3-4 times a day. Children 6 to under 12 years old: 5 mL 3-4 times a day.

Label contents#

Full prescribing information#

Warnings 

WARNINGS SECTION

The following side effects may occur, nausea, vomiting, dizziness, headache, or nervousness may occur, if any of these effects last or worsen, contact your doctor or pharmacist immediately.  Stop using this medicine and tell your doctor right away if you have dizziness, nervousness, or trouble sleeping. 

OTC-PURPOSE SECTION

OTC - PURPOSE SECTION

Antitussive

Antihistamine

OTC - Active Ingredient Section

Dextromethorphan HBr

Mepyramine maleate

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms in all formsof acute, subacute, and cronical cough of any origin, it is very effective in colds, rhinitis, pharyngitis, laryngitis, dry cough, smokers cough, ashma, nervous cough.

Do Not Use

OTC - DO NOT USE SECTION

Stop using this medicine and contact your doctor right away if any of these unlikely but serious side effects occur, fast and irregular heartbeat, mental mood changes such as confusion, hallucinations, nervousness, seizures, tremor, problems with to pee.

If you are taking any monoamine oxidase inhibitor (MAOI), or two weeks after stopping them (certain medications for depression or psycological conditions may contain them).  If you are not sure if your prescription contains an MAOI, coinsult a professional of health before taking this product.

Ask a doctor/pharmacist 

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if yoy have

Liver disease, heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to enlarged prostate gland, cough that occurs with too much phlegm (mucus), presistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Symptoms last more than 7 days, symptoms worsen or come back, you develop a headache that wont go away, fever, or skin rash.  If pregnant or breast-feeding ask a health professional before use.

Keep Out of the Reach of Children 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional help or go to poison control center immediately.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Do not exceed 4 doses in a 24 hour period.

Adult and children 12 years and older: 10 mL 3-4 times a day.

Children 6 to under 12 years old: 5 mL 3-4 times a day.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Sugar, Sodium Benzoate, FD&C Yellow #5, Orange flavor, MEthyl  paraben, Propyl paraben, ethyl alcohol 95%, Sorbitol 70%, Purified water.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Broncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpg

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BroncochemMaximumCoughNight_BoxProductionFile_v3 (002)-01.jpgBroncochemMaximumCoughNight_BoxProductionFile_v3 (002)-01.jpgBroncochemMaximumCoughNight_BoxProductionFile_v3 (002)-01.jpgBroncochemMaximumCoughNight_BoxProductionFile_v3 (002)-01.jpgBroncochemMaximumCoughNight_BoxProductionFile_v3 (002)-01.jpgBroncochemMaximumCoughNight_BoxProductionFile_v3 (002)-01.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2712157dextromethorphan HBr 30 MG / pyrilamine maleate 50 MG in 5 mL Oral SolutionPSN1
2712157dextromethorphan hydrobromide 6 MG/ML / pyrilamine maleate 10 MG/ML Oral SolutionSCD1
2712157dextromethorphan HBr 30 MG / pyrilamine maleate 50 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65131-110-35BRONCOCHEMMAXIMUM COUGH NIGHT120 mL in 1 BOTTLE, PLASTICSYRUP1201
65131-110-35BRONCOCHEMMAXIMUM COUGH NIGHT1 in 1 BOXSYRUP11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65131-110BRONCOCHEM MAXIMUM COUGH NIGHT (DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL]1Current NDC, 2 package rows20250421_dffdfa2c-a52e-4606-9b07-c8993e499f09.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65131-11065131-110-35

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRONCOCHEM MAXIMUM COUGH NIGHTDEXTROMETHORPHAN HBR-PYRILAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRLdffdfa2c-a52e-4606-9b07-c8993e499f092025-03-23WarningsExact identifier
ndc (package): 65131-110-35
ndc (product): 65131-110
ndc11 (package): 65131011035
spl id: daa4b9dd-bc1f-429e-a32b-613f1b6987e8
spl set id: dffdfa2c-a52e-4606-9b07-c8993e499f09

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.